BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant,

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814671·GENUMEDI SILVER SIZE IV

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123854·K-WIRE - DOUBLE TROCAR 2.0mm DIA x 100mm

    PMD VIEWER

    FDA 510(k)
    FDA Class 2 ·Radiology

    CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·May 14, 2018

    PRECISE PRO RX CAROTID STENT SYSTEM

    FDA Adverse Event
    Death ·CORDIS DE MEXICO·Product code NIM·October 7, 2008

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code CBK·June 20, 2013

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·August 4, 2011

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·February 8, 2024

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 2025

    PU-681RA

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·September 16, 2025

    Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    Alcon Custom Ophthalmic Surgical Procedure Packs

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·April 7, 2021